suzhou, january 15, 2021 - alphamab oncology (stock code: 9966 hk) announced dosing of the first patient in the enreach-thymic registration trial with kn046, developed by alphamab oncology, for the treatment of thymic cancer.
enreach-thymic trial is a phase ii, open label, multi-center pivotal clinical study to evaluate efficacy, safety and tolerability of kn046 in subjects with thymic carcinoma. this study is going to be conducted at about 15 clinical sites, and planed to enroll about 66 patients. the primary endpoint is the objective response rate (orr) evaluated by the independent review committee (irc) according to the recist 1.1 criteria. enreach-thymic is based on the clinical data of kn046 phase i trial for the treatment of thymic epithelial tumors. the detailed data will be presented at the 2020 world conference on lung cancer.
thymic carcinoma is a rare and aggressive thymic tumor. inoperable or metastatic thymic cancer has a very poor prognosis. for patients who have failed 1st line platinum-containing chemotherapy, there is currently no approved standard treatment; the objective response rate of late-line chemotherapy or targeted therapy is usually less than 20%, and the median survival time is less than 12 months. there is an urgent unmet medicall need for effective therapeutics to improve the survival benefits.
the primary investigator of enreach-thymic, professor xiaolong fu, director of radiotherapy department, shanghai chest hospital commented, “thymus is an important organ for t cell development. thymic epithelial tumors highly express pd-l1, so patients are likely to benefit from immune checkpoint inhibitors therapy. we are very pleased to see the good safety, high response rate and long-lasting response time of the pd-l1/ctla-4 bispecific antibody kn046 in the treatment of patients with thymic tumors in the previous clinical trials. we hope this phase ii registered clinical study can be proceed smoothly to solve the unmet clinical needs.”
the co-primary investigator of enreach-thymic, professor wentao fang, director of thoracic surgery department, shanghai chest hospital commented, “thymic tumors are rare tumors derived from thymic epithelium. refractory or recurrent advanced thymic tumors lack standard and effective treatment options, and the prognosis is poor. we hope to see positive data from the enreach-thymic study as soon as possible and bring new treatment options to patients.”
dr. ting xu, founder, chairman and ceo of alphamab oncology commented, “pd-(l)1 and ctla-4 are two clinically validated immune oncology targets. kn046 is a global leadingpd-l1/ctla-4 bispecific antibody with the. in austrialia phase i cl trial, encouraging results have been observed forthymic epithelial tumors. meanwhile, kn046obtained the orphan drug designation for thymic epithelial tumor from us fda. dosing of the first patient in this phase ii registration study is another important milestone in the global development for kn046. we expect that this innovative therapeutics become a breakthrough therapy for the treatment of thymic tumors and bring significant survival benefits to patients.”
kn046 is pd-l1/ctla-4 bispecific antibody independently developed by jiangsu alphamab. its innovative designs include: a different mechanism ctla-4 fused with pd-l1 single domain antibody; engineered to target the tumor microenvironment with high pd-l1 expression, and treg（suppress tumor immunity） clearing function.
there are about 20 clinical trials of kn046 in different stages covering more than 10 types of tumors including nsclc, tnbc, escc, hcc and pancreatic cancer in australia and china. the results of these clinical trials have shown an advantage in survival for patients. alphamab has received fda clearance to enter phase ⅱ trial of kn046 based on the clinical results in china and australia. moreover, kn046 has obtained the u.s. fda's orphan drug designation for thymic epithelial tumor in september, 2020. two registrational clinical trials are currently being conducted.
about alphamab oncology
alphamab oncology is a biopharmaceutical company focusing on innovative biologics medicine for oncology. on december 12, 2019, the company was listed in the mainboard of hong kong stock exchange with stock code 9966.
alphamab has fully integrated proprietary biologics platforms in bi-specifics and protein engineering. its pipeline includes eight anti-tumor drug candidates including mainly bi-specifics, and a covid-19 multifunctional antibody. four products have advanced into phase i-iii clinical trials in china, the united states, japan, and australia. the bla for kn035(envafolimab) has been accepted by the national medical products administration (nmpa) on december 17.
the company also has state-of-the-art manufacturing capabilities designed and built to meet nmpa and eu/fda’s cgmp standards and a complete quality system which has passed the on-site inspection of an european union qualified person. alphamab oncology is committed to building a global leading, multi-dimensional drug development and commercialization platform, focusing on multifunctional biological innovative drugs, and to benefit patients in china and around the world.
visit http://www.alphamabonc.com for more information.
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